Pregabalin and Radicular Pain Study (PARPS)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01061697
First received: February 2, 2010
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve pain worldwide


Condition Intervention Phase
Cervical Spondylosis
Cervical Spondylotic Myelopathy
Cervical Spondylotic Radiculopathy
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS): Pain ruler done daily [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-Form McGill Pain Questionnaire (SFMPQ) [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Patient and Clinical Global Impression of change [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pregabalin
    At week 0, pregabalin 75mgbd will be given for 1 month. If visual analogue scale is not reduced by 50% after 1 month, pregabalin will be increased to 150mgbd for the second month
    Other Name: Brand name: Lyrica
Detailed Description:

The treatment of neuropathic pain is clinically challenging, and pain from cervical spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)).

Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established. Additionally, there are no data to date on its use in Asian patients.

In this study, we prospectively evaluate its efficacy for treating neuropathic pain in degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and investigator rated scoring will be implemented.

The results will be of value in the non-operative management of CS.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical & MRI, or electrophysiological evidence of pain due to radiculopathy
  • Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).

Exclusion Criteria:

  • Diabetic neuropathy or other underlying neuropathic conditions
  • Contraindications and allergy to pregabalin
  • Previously treated with gabapentin in the last 8 weeks
  • Pregnant or breast feeding
  • History of renal impairment
  • History of other causes of neuropathic pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061697

Locations
Singapore
Singapore General Hospital
Singapore, Outram Road, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Pfizer
Investigators
Principal Investigator: Y L Lo, MD National Neuroscience Institute, Singapore General Hospital
  More Information

No publications provided

Responsible Party: A/Prof Lo Yew Long, National Neuroscience Institute, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01061697     History of Changes
Other Study ID Numbers: #2006/072/A
Study First Received: February 2, 2010
Last Updated: July 4, 2011
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Spondylosis
Radiculopathy
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014